Wednesday, July 8, 2026

Drug profile · INN

cobimetinib fumarate

cobimetinib fumarate (COTELLIC) is a dual specificity mitogen-activated protein kinase kinase 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — cobimetinib fumarate
US status
approved
Class
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

cobimetinib fumarate (COTELLIC) is a dual specificity mitogen-activated protein kinase kinase 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN cobimetinib fumarate
Brand COTELLIC
Mechanism Dual specificity mitogen-activated protein kinase kinase 2 inhibitor
Target Dual specificity mitogen-activated protein kinase kinase 1
Route ORAL
Formulation TABLET

Mechanism of action

Dual specificity mitogen-activated protein kinase kinase 2 inhibitor

Primary target: Dual specificity mitogen-activated protein kinase kinase 1

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. COBI Phase 3 · Gilead Sciences Ireland · HIV
  2. Cobimetinib Phase 1 · Cardiff Oncology · Locally Advanced Pancreatic Ductal Adenocarcinoma

Related & competitor drugs

  1. binimetinib Antineoplastic and immunomodulating agents (L01)
  2. mirdametinib Antineoplastic and immunomodulating agents (L01)
  3. selumetinib sulfate Dual specificity mitogen-activated protein kinase kinase; MEK1/2 inhibitor
  4. trametinib dimethyl sulfoxide Dual specificity mitogen-activated protein kinase kinase 2 inhibitor
  5. cobimetinib Antineoplastic and immunomodulating agents (L01)
  6. refametinib Dual specificity mitogen-activated protein kinase kinase 2 inhibitor

Frequently asked questions

What is cobimetinib fumarate?

cobimetinib fumarate (COTELLIC) is a dual specificity mitogen-activated protein kinase kinase 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for cobimetinib fumarate?

COTELLIC is a marketed brand name for cobimetinib fumarate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of cobimetinib fumarate?

cobimetinib fumarate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.